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| Name | Class |
|---|---|
| Admescope Ltd | INDUSTRY |
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Midline laparotomy is commonly used in emergency and elective cancer surgery and patients need effective and safe pain treatment after this type of surgery. Nowadays modern anticoagulant therapy may prevent use of central regional blocks in pain management. Therefore in the present study the efficacy and safety of rectus sheath analgesia is studied using different administration techniques. The primary aim is the efficacy of the rectus sheath analgesia measured with pain ratings and the amount rescue opioid used.
Secondary aims were concentrations of local anesthetic, rescue opioid and satisfaction to analgesia method used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous rectus sheath analgesia | Active Comparator | Local anesthetic continuous infusion with infusion pumps |
|
| Bolus rectus sheath analgesia | Active Comparator | Bolus administration of local anesthetic |
|
| Single dose rectus sheath analgesia | Active Comparator | single dose administration of local anesthetic |
|
| Placebo | Placebo Comparator | no rectus sheath analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine continuous infusion | Drug | Levobupivacaine continuous infusion to rectus sheath catheters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Amount of rescue analgesic used for pain relief | From onset of rectus sheath analgesia | Time 0 h up to 48 h postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum levobupivacaine plasma concentration | Maximum levobupivacaine plasma concentration | Time 0 h to 48 h postoperatively |
| maximum rescue analgesic concentration | maximum rescue analgesic concentration |
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Inclusion Criteria: • Body mass index over BMI <35 kg / m2
Exclusion Criteria:
• BMI >35 kg / m2
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| Name | Affiliation | Role |
|---|---|---|
| Matti Eskelinen, Professor | Kuopio University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio University Hospital | Kuopio | Northern Savonia | 70029 | Finland |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| levobupivacaine bolus dosing | Drug | Levobupivacaine bolus dosing to rectus sheath catheters |
|
|
| single bolus of levobupivacaine | Drug | Levobupivacaine single dose to rectus sheath catheters |
|
|
| Placebo | Other | No rectus sheath analgesia |
|
|
| time 0 h to 48 h postoperatively |
| D012816 | Signs and Symptoms |